| European CommissionJRCIHCPTSAR |
| Regulatory Approval |
| Stage 1: Technical Discussions with EU Experts |
| Technical Discussion by EU experts via the National Coordinators from the Member States of the draft method proposal. The EU test guidelines Coordinator (within JRC) sends the complete set of documentation concerning a new scientifically validated alternative test method, including a test protocol, to the Member States' National Coordinators by e-mail, giving them a deadline of two months within which to provide comments and give their positions [the NCs need to send the documentation to their networks of experts, then gather and summarise comments and possibly organise a meeting to agree on a position]. At the same time, the EU Coordinator sends the documentation to ECHA and to other Commission services as appropriate, which may provide comments within the same time frame. |
| Complete Summarised Scheme Explanatory note to the revised procedure: The streamlined procedure deals with regulatory acceptance of an alternative test method at EU level. It is important to underline that this does not represent a new procedure; it simply clarifies and streamlines the steps that must be followed if the Commission decides to pursue regulatory acceptance at EU level. It is very clear, particularly following discussions with both the Competent Authorities and the European Parliament, that a new scientifically validated alternative test method will, in the first instance, be submitted to the OECD regulatory acceptance process. It is only in exceptional cases, if there is "undue delay" in the OECD process, that the Commission would then take a decision to "switch" to the EU process. |